ADVIA Chemistry Urea Nitrogen Reagent (material number… recallZ-2062-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 27, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
FDA root cause category: Material/Component Contamination
What the company is doing
Date recall was initiated: 03-27-18 Customer communication was sent on 04-03-18 Urgent Medical Device Recall (CHC18-04.A.US) was distributed to all customers in the United States and an Urgent Field Safety Notice (CHC18-04.A.OUS) was distributed to all customers outside the United States who have received ADVIA Chemistry Urea Nitrogen reagent kit lots 408143 and 418290 (Lot 418290 was not sold in the US). These letters instruct the customers to discontinue use of reagent kit lots 408143 and 418290 and to contact their Customer Care Center for replacements kits. In the US the method of distribution is Fed Ex and outside the US the distribution is determined at the country level.
Recall details
- Recall number
- Z-2062-2018
- Status
- Terminated
- Initiated by the company
- Mar 27, 2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product code
- CDQ
- FDA submissions
- K991576
- Distribution
- Nationwide and worldwide
Product description
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Code information (models, lots, serial numbers)
Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ADVIA® Chemistry UN Urea Nitrogen Reagents 10309051Siemens Healthcare Diagnostics Inc. · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN1 recall0 reports
Other devices under the same FDA submission
6 devices cleared under K991576 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ADVIA® Chemistry IRON_2 Iron 2 Reagents 10377510Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)1 recall1 report
- Atellica CH Iron_2 11097601Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)1 recall1 report
- ADVIA® Chemistry IRON_2 Reagents 10341118Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)1 recall0 reports
- Atellica CH Ca 11097595Siemens Healthcare Diagnostics Inc. · CRESOLPHTHALEIN COMPLEXONE, CALCIUM14 reports
- ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated 10283346Siemens Healthcare Diagnostics Inc. · ALKALINE PICRATE, COLORIMETRY, CREATININE1 report
- Atellica CH IP 11097611Siemens Healthcare Diagnostics Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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